AUKELSO 120 mg/1.7mL
Denosumab-kyqq · INJECTION · Biocon Biologics Inc.
AUKELSO is a injection containing denosumab-kyqq at 120 mg/1.7mL, taken subcutaneous. Manufactured by Biocon Biologics Inc..
Key Facts
- Brand Name
- AUKELSO
- Generic Name
- Denosumab-kyqq
- NDC Code (Product)
83257-030- Manufacturer
- Biocon Biologics Inc.
- Strength
- 120 mg/1.7mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761436
- Drug Class
- RANK Ligand Inhibitor [EPC]
- Marketing Start
- 01/05/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Aukelso is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Aukelso is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Aukelso is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Aukelso is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Aukelso should be administered by a healthcare provider. ( 2.1 ) Aukelso is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally. ( 2.1 ) Multiple Myeloma and Bone Metastasis from Solid Tumors: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen. ( 2.2 ) Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. ( 2.3 ) Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia. ( 2.2 , 2.3 ) Hypercalcemia of Malignancy: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. ( 2.4 ) 2.1 Important Administration Instructions Aukelso should be administered by a healthcare provider. Aukelso is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally. 2.2 Multiple Myeloma and Bone Metastasis from Solid Tu…
Contraindications
4 CONTRAINDICATIONS Hypocalcemia ( 4.1 ) Known clinically significant hypersensitivity to denosumab products (4.2 ) 4.1 Hypocalcemia Pre-existing hypocalcemia must be corrected prior to initiating therapy with Aukelso [see Warnings and Precautions (5.3) ]. 4.2 Hypersensitivity Aukelso is contraindicated in patients with known clinically significant hypersensitivity to denosumab products [see Warnings and Precautions (5.2) and Adverse Reactions (6.2) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed below and elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.2) ] Hypocalcemia [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fracture [see Warnings and Precautions (5.5) ] Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons [see Warnings and Precautions (5.6) and Use in Specific Populations (8.4) ] Multiple vertebral fractures (MVF) following treatment discontinuation [see Warnings and Precautions (5.7) ] Bone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. ( 6.1 ) Multiple Myeloma: Most common adverse reactions (≥ 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. ( 6.1 ) Giant Cell Tumor of Bone: Most common adverse reactions (≥ 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in ext…
Frequently Asked Questions
What is AUKELSO used for?
AUKELSO contains Denosumab-kyqq. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is AUKELSO a controlled substance?
AUKELSO is not classified as a controlled substance by the DEA.
What is the generic name for AUKELSO?
The generic name for AUKELSO is Denosumab-kyqq. There are 1 other brand versions of Denosumab-kyqq.
What is the NDC code for AUKELSO 120 mg/1.7mL?
The NDC (National Drug Code) for AUKELSO 120 mg/1.7mL is 83257-030, listed by Biocon Biologics Inc..